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Sponsored by: |
Catalan Institute of Health |
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Information provided by: | Catalan Institute of Health |
ClinicalTrials.gov Identifier: | NCT00137579 |
Until now, the best administration route of the anti-flu vaccine for patients receiving long term oral anticoagulation therapy has been the subcutaneous one; the intramuscular route has not been recommended because it may increase the risk of muscular haematoma. Although this practice is widely extended, no significant differences between the safety of both routes have been found. Some authors, analysing a small group of patients, affirm that the anti-flu vaccine can be administered safely by the intramuscular route on patients receiving long term oral anticoagulation therapy, while a previous opinion article recommended the subcutaneous route without any scientific evidence. Due to this, the investigators have done a clinical trial with the aim of determining the safety and effectiveness of the flu-vaccine intramuscular route in patients receiving long term oral anticoagulation therapy and also to analyse the possible interactions between the vaccine and the oral anticoagulant treatment.
Condition | Intervention | Phase |
---|---|---|
Influenza |
Procedure: Influenza vaccine intramuscular administration route |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase IV, Simple Blind, 2-Parallel Groups Randomized Trial to Evaluate the Safety and Effectiveness of the Intramuscular Vs Subcutaneous Route for the Administration of the Anti-Flu Vaccine in Patients Receiving Oral Anticoagulation |
Estimated Enrollment: | 216 |
Study Start Date: | September 2003 |
Estimated Study Completion Date: | May 2004 |
Phase IV, simple blind, 2-parallel groups, multicentric randomized trial where each patient will receive a single dose of the recommended by the WHO anti-flu vaccine for the 2003-2004 period, the control group will receive it subcutaneous and intervention group intramuscular. The assignation to each group will be randomized. The study included 4 basic areas of Barcelona city. Three visits have been scheduled for each patient: moment 0, 24 hours and 10 days after the vaccination, and a 7 month follow up period to control the incidence of the flu.
Ages Eligible for Study: | 18 Years to 95 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Spain | |
Casc Antic | |
Barcelona, Spain, 08003 | |
Raval Sud | |
Barcelona, Spain, 08001 | |
Raval Nord | |
Barcelona, Spain, 08001 | |
Gotic | |
Barcelona, Spain, 08002 |
Principal Investigator: | Josep Casajuana, Physician | Catalan Institute of Health |
Study Chair: | Elvira Givert, Nurse | Catalan Institute of Health |
Study Chair: | Josep Franch, Physician | Catalan Institute of Health |
Study Chair: | Clara Sala, Nurse | Catalan Institute of Health |
Study Chair: | Miriam Aballi, Physician | Catalan Institute of Health |
Study Chair: | Begoña Iglesias, Physician | Catalan Institute of Health |
Study Chair: | Joan Antoni Valles, Physician | Catalan Institute of Health |
Study Chair: | Maria del Mar Piqueras, Physician | Catalan Institute of Health |
Study Chair: | Paz Escobar, Nurse | Catalan Institute of Health |
Study Chair: | Antonia Moreno, Nurse | Catalan Institute of Health |
Study Chair: | Montserrat Català, Nurse | Catalan Institute of Health |
Study Chair: | Anna Maria Ramirez, Nurse | Catalan Institute of Health |
Study Chair: | Maria Queralt Capdevila, Nurse | Catalan Institute of Health |
Study Chair: | Merce Botinas, Physician | Catalan Institute of Health |
Study Chair: | Lilia Villagrassa, Nurse | Catalan Institute of Health |
Study Chair: | Josep Maria Segura, Physician | Catalan Institute of Health |
Study Chair: | Maria del Mar Ballester, Physician | Catalan Institute of Health |
Study Chair: | Gustavo Losada, Physician | Catalan Institute of Health |
Study Chair: | Maria Teresa Maudos, Physician | Catalan Institute of Health |
Study ID Numbers: | SINGRIP03 |
Study First Received: | August 29, 2005 |
Last Updated: | December 12, 2005 |
ClinicalTrials.gov Identifier: | NCT00137579 History of Changes |
Health Authority: | Spain: Spanish Agency of Medicines |
Influenza Vaccines Acenocoumarol Drug Administration Routes Anticoagulants |
Virus Diseases Anticoagulants Respiratory Tract Diseases Respiratory Tract Infections |
Acenocoumarol Influenza, Human Orthomyxoviridae Infections |
Virus Diseases RNA Virus Infections Respiratory Tract Diseases |
Respiratory Tract Infections Influenza, Human Orthomyxoviridae Infections |